Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000

Completed

Conditions studied: Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation, Aortic Valve Disease, Tricuspid Regurgitation

In brief

The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive FloWave™ 1000 device.

Key facts

Study ID

NCT00665301

Run by

Woolsthorpe Technologies, LLC

People needed

54

Starts

2008-03-01

Expected to finish

2008-06-01

Last updated by the study team

2008-07-08

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults Only: The FloWave device is intended for use on adult patients only. All subjects will be 18 years or older.
• Existing placement of a Pulmonary Arterial Catheter placed for medical reasons other than our study.

You may not qualify if…

• Patients with aortic balloon pumps and cardiac mechanical assist devices will be excluded from study enrollment if the devices are present during the screening process. If patients have cardiac assist devices inserted after enrollment in the study, cardiac output data will be collected with both the PAC and FloWave device and will be evaluated as a subset analysis population at the conclusion of the study.
• Patients with intracardiac shunts will be excluded from this study.
• FloWave cardiac output determinations are dependent on detection of a pulse. If no peripheral pulse can be detected the device will not be able to perform a measurement and this will be indicated to the user.
• Patients who are not in a steady hemodynamic state shall be excluded from the study.
• Presence of arrhythmias: Patients with arrhythmias are excluded from the study when not in a steady hemodynamic state. If a patient has a history of arrhythmia or is currently experiencing an arrhythmia but is in a maintained hemodynamic state, they will not be excluded from enrollment into the study. Their clinical symptoms and cardiac rhythm will be evaluated and noted in the patient data record.
• Inability or unwillingness of subject or the subject's legally authorized representative to give informed consent.

Where it is running

• St. Thomas Hospital — Nashville, Tennessee, United States
• Vanderbilt University Hospital — Nashville, Tennessee, United States
• Texas Heart Institute - St. Luke's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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